Safety of SPD465 in Treating Adults With ADHD.
A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
1 other identifier
interventional
505
0 countries
N/A
Brief Summary
The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2006
CompletedAugust 23, 2021
August 1, 2021
1.7 years
September 7, 2005
August 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.
Throughout the study period of approximately 20 months
Secondary Outcomes (3)
ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.
Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).
Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.
Baseline, Weekly for 4 weeks, and then Monthly for 5 months.
Interventions
Eligibility Criteria
You may qualify if:
- Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
- Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.
You may not qualify if:
- Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
- Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
- History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
- Females who are pregnant of lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 9, 2005
Study Start
March 10, 2005
Primary Completion
November 7, 2006
Study Completion
November 7, 2006
Last Updated
August 23, 2021
Record last verified: 2021-08